A Clinical Study of Enlicitide and the Effect of Food in Healthy Adult Participants (MK-0616-033)

NCTNCT06609512Other id0616-033Other idMK-0616-033

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Overview

Status: Completed
Phase: Phase 1
Enrollment: 20 participants (actual)
Sponsor: Merck Sharp & Dohme LLC · Industry
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: 21 Oct 2024
Primary completion: 13 Jan 2025
Completion: 31 Jan 2025
First posted: 24 Sept 2024
Last update posted: 7 Feb 2025
Conditions: Healthy

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202420252026

Ph 1
A Clinical Study of Enlicitide and the Effect of Food in Healthy Adult Participants (MK-0616-033)
NCT06609512
21 Oct 2024 to 31 Jan 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The goal of the study is to learn what happens to enlicitide decanoate in a healthy person's body over time when taken on an empty stomach or with food. Researchers will compare what happens to enlicitide in a healthy person's body over time when enlicitide is taken with or without food. Enlicitide decanoate will be referred to as "enlicitide" throughout.

Interventions

EnlicitideDrug

Arms4

Experimental
Enlicitide Treatment A
Participants receive single oral dose of enlicitide after 8-hour overnight fast.
Experimental
Enlicitide Treatment B
Participants receive single oral dose of enlicitide 4 hours after morning meal.
Experimental
Enlicitide Treatment C
Participants receive single oral dose of enlicitide 3 hours after morning meal.
Experimental
Enlicitide Treatment D
Participants receive single oral dose of enlicitide 2 hours after morning meal.

Primary outcomes9

Outcomes the sponsor listed as primary.

Area Under the Concentration versus Time Curve from 0 to Infinity (AUC0-inf) of enlicitide in plasma
Time frame · Pre-dose and at designated time points up to 168 hours post dose
Registry description
AUC0-inf of enlicitide in plasma will be determined.
Area Under the Concentration versus Time Curve from Time 0 to 24 hours (AUC0-24) of enlicitide in plasma
Time frame · Pre-dose and at designated time points up to 24 hours post dose
Registry description
AUC0-24 of enlicitide in plasma will be determined.
Area under the concentration versus time curve from time 0 to last quantifiable sample (AUC0-last) of enlicitide in plasma
Time frame · Pre-dose and at designated time points up to 168 hours post dose
Registry description
AUC0-last of enlicitide in plasma will be determined.
Maximum plasma concentration (Cmax) of enlicitide in plasma
Time frame · Pre-dose and at designated time points up to 168 hours post dose
Registry description
Cmax of enlicitide in plasma will be determined.
Time to maximum plasma concentration (Tmax) of enlicitide in plasma
Time frame · Pre-dose and at designated time points up to 168 hours post dose
Registry description
Tmax of enlicitide in plasma will be determined.
Apparent terminal half-life (t1/2) of enlicitide in plasma
Time frame · Pre-dose and at designated time points up to 168 hours post dose
Registry description
t1/2 of enlicitide in plasma will be determined.
Apparent Clearance (CL/F) of enlicitide in plasma
Time frame · Pre-dose and at designated time points up to 168 hours post dose
Registry description
CL/F of enlicitide in plasma will be determined.
Apparent volume of distribution during terminal phase (Vz/F) of enlicitide in plasma
Time frame · Pre-dose and at designated time points up to 168 hours post dose
Registry description
Vz/F of enlicitide in plasma will be determined.
Lag Time (tlag) of enlicitide in plasma
Time frame · Pre-dose and at designated time points up to 168 hours post dose
Registry description
tlag is the time from dosing to the first appearance in plasma. The tlag of enlicitide in plasma will be determined.

Secondary outcomes(2)

Number of participants who experience one or more adverse events (AEs)
Time frame · Up to ~ 14 days
Registry description
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Number of participants who discontinue study intervention due to an AE
Time frame · Up to ~ 14 days
Registry description
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 55 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: The main inclusion criteria include but are not limited to the following: \- Has body mass index (BMI) ≥18 kg/m\^2 and ≤32 kg/m\^2 Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * History of gastrointestinal disease which may affect food and drug absorption, or has had a gastric bypass or similar surgery * History of cancer (malignancy) * Positive test(s) for Hepatitis B surface antigen (HBsAg), hepatitis C antibodies or Human immunodeficiency virus (HIV) * History of a major surgery * Is lactose intolerant

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